[ Price : $8.95]
FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submi...[ Price : $8.95]
Rep. Jake Auchincloss calls on FDA to affirm or refute his conclusion that the Commissioners National Priority Voucher program may...[ Price : $8.95]
An FDA-authored journal article signals a supportive but cautious regulatory posture toward the development of chimeric antigen re...[ Price : $8.95]
FDA issues an early alert to warn clinicians about a potentially high-risk issue affecting certain Abiomed heart pump devices used...[ Price : $8.95]
HHS Office of Inspector General begins an ethics investigation into FDA deputy chief of staff Samuel Doran and whether he misled t...[ Price : $8.95]
FDA sends Aquestive Therapeutics a complete response letter for its NDA for Anaphylm, a sublingual epinephrine film for treating T...[ Price : $8.95]
FDA launches its new PreCheck pilot program aimed at strengthening domestic pharmaceutical manufacturing by providing earlier regu...[ Price : $8.95]
A patient safety advocacy group files a citizen petition urging FDA to create a comprehensive public database of medical device la...